Director, Pharmacovigilance Quality Management System

Position: Director, Pharmacovigilance Quality Management System       

Reports to:  VP, Global Pharmacovigilance, Safety and Risk Management        

Location:  U.S.         

Summary: Reporting to the VP, Global Pharmacovigilance, Safety and Risk Management, you will be responsible for Pharmacovigilance Quality Management Systems.  The strategic leader will be accountable for developing and overseeing the pharmacovigilance QMS for all GPSRM functions. These functions include scientific, medical, and operational aspects of PV as well as vendor oversight.

Specific Responsibilities:

• Develop and establish a quality management program for GPSRM including developing and monitoring performance metrics and key performance indicators to improve the performance and compliance across the organization and assure continuous quality improvement.
• Support the development and maintenance of global PV department procedures (SOPs) and working instructions in collaboration with subject matter experts to ensure that the procedures are timely updated, and accurately reflect the best practice standards and PV regulations.
• Management of GPSRM participation in regulatory authority inspections and audits.
• Develops and manages PV-related training curricula and training compliance.
• Functions as GPSRM representative to Corporate Quality Committee.
• Develop, manage and updates of Pharmacovigilance System Master File.
• Develops procedures for vendor management and oversight as well as having direct management responsibilities for vendors involved in writing PSMF and country operations.
• Maintains an in-depth knowledge of global safety regulations and requirements including but not limited to FDA, EMA, Switzerland, and UK.

Qualifications / Requirements:

• Master's degree or bachelor’s degree in a life science, health care, or pharmaceutical-related field.
• At least 10 years relevant pharmaceutical experience, at least 5 years with a focus on pharmacovigilance.
• Prior experience in PV quality monitoring and system development.
• Leadership skills in working with all levels of management and consulting with key business stakeholders
• Well-developed presentation, communication and interpersonal skills, including strong oral and written communication skills.

Preferred Experience, Special Skills, Knowledge:

• Experience supporting/leading regulatory agency inspections.
• Strong knowledge base of GVP and global pharmacovigilance regulations.
• Demonstrated ability to devise processes which are innovative and fit-for-purpose.